MAUDE Adverse Event Report: ARTHREX, INC. HUM INSERT S/36+6 TO FIT IN 36 CUP CONST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUM INSERT S/36+6 TO FIT IN 36 CUP CONST
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a revision was needed; the original dos was (b)(6) 2019 (no exact date known), the case was a reverse shoulder with modular glenoid system.The patient was experiencing pain and x-ray showed that the whole construct has dislocated.It is not known if the patient was non-compliant.On (b)(6) 2020, they removed ar-9503s-06c humeral insert; it was the only part from the original surgery that was removed; it was replaced with ar-9555-06 revers spacer and ar-9503s-03c humeral insert.Patient is male, (b)(6) years.

• Brand Name: HUM INSERT S/36+6 TO FIT IN 36 CUP CONST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10055548
• Report Number: 1220246-2020-01831
• Device Sequence Number: 2812774
• Product Code: PHX
• UDI-Device Identifier: 00888867061323
• UDI-Public: 00888867061323
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HUM INSERT S/36+6 TO FIT IN 36 CUP CONST
• Device Catalogue Number: AR-9503S-06C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR